Trial document




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  DRKS00012914

Trial Description

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Title

Brandenburg Enhance Activity Onset after pulmonary vein Isolation - BE ACTION

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Trial Acronym

BE ACTION

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URL of the Trial

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Brief Summary in Lay Language

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Brief Summary in Scientific Language

This is an interventional study investigates effects of an enhance physical activity in patients with atrial fibrillation (AF) and planed pulmonary vein isolation (PVI).
200 patients with AF and planed PVI, age 50-77 years, BMI 23 - 35 kg/m² and underwritten patient informed consent form will enclosed to this study.
Exclusion criteria are physical disability, reduced capacity and patients who are not able to wear an activity tracker. After screening and enclusion prozedure all patients received an POLAR activity tracker before PVI. The patients decides by themself about the additional implantation of loop recorder.
After PVI all patients will randomized by 1:1 to standard of care verus additional enhance physical activity. All patients will send their activity data all 7 days up to 12 month to the study center. Patient in the enhance activity arm will indroduced, lead and controlled to doubling their daily steps or minimal 6,000 steps per day by a physiotherapist.
For rhythm controll patients without loop recorder will followed up by 7 day ECG at 6 and 12 month and patients with loop recorder will followed up continuously by remote data transfer.
The primary endpoint are any AF or atrial flutter episodes >30s, additional ablation prozedure or
new onset of antiarrhythmic drugs earliest after 90 days after index PVI.

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Organizational Data

  •   DRKS00012914
  •   2017/08/30
  •   [---]*
  •   yes
  •   Approved
  •   S18(a)/2017, Ethik-Kommission der Landesärztekammer Brandenburg
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Secondary IDs

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Health Condition or Problem studied

  •   I48.0 -  Paroxysmal atrial fibrillation
  •   I48.1 -  Persistent atrial fibrillation
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Interventions/Observational Groups

  •   Intervention arm:

    Due to baseline activity data from the patient at the two weeks after pulmonary vein isolation an individual activity aim will definited together with the physiotherapist. A minimal aim of 6,000 step per day or doubeling the baseline activity will establish. Every 14 days the patient will get an individual feed back from their current activity data. If the patient does not meet the aim, vocal motivation will give by telephone call. If the patient does not meet the aim after additional 14 days the patient must write an activity diary and further outpatient meeting to bring the patient to a higher activity level. In case of implanted loop recorder a remote continuously rhythm control will organize up to 12 month. For all patients a outpatient follow up is planed at 6 month and 12 month including clinical investigation and questionnaire.
    All patient must use the activity tracker and send the data to our Center.
  •   Control arm:

    For all patients a outpatient follow up is planed at 6 month and 12 month including clinical investigation and questionnaire. In case of remote rhythm control by loop recorder a continuously rhythm control will organized. All patient must use the activity tracker and send the data to our center but no aims of activity or further motivation will defined.
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Control group receives no treatment
  •   Treatment
  •   Parallel
  •   IV
  •   N/A
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Primary Outcome

new onset of AF or atrial flutter episodes >30s, additional ablation prozedure or
new onset of antiarrhythmic drugs (I and III classes) earliest after 90 days after index PVI

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Secondary Outcome

An improved outcome in terms of disease, re-hospitalization of cardiovascular events and complications using the following parameters: NTpro-BNP course, survey and questionnaires to perception of illness

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Actual
  •   2018/01/26
  •   200
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   50   Years
  •   77   Years
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Additional Inclusion Criteria

- Age: 50 - 77 years
- BMI: 23 - 35 kg/m²
- atrial fibrillation with pulmonary vein isolation is planned
- patient informed consent (PIC) is signed

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Exclusion Criteria

- error of capacity
- physical handicap, which hinder activities
- noncompliance to be active and wear a fitnesstracker

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Addresses

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    • Immanuel Klinikum Bernau Herzzentrum BrandenburgChefarzt der Kardiologie
    • Mr.  Univ.-Prof. Dr. med.  Christian  Butter 
    • Ladeburger Straße 17
    • 16321  Bernau
    • Germany
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    •   03338/69-4610
    •   03338/69-4616
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    •   [---]*
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    • Immanuel Klinikum Bernau Herzzentrum Brandenburg
    • Mr.  Dr. med.  Martin  Seifert 
    • Ladeburger Straße 17
    • 16321  Bernau
    • Germany
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    • Immanuel Klinikum Bernau Herzzentrum BrandenburgKardiologische Studienambulanz
    • Ms.  Anne-Katrin  Hübner 
    • Ladeburger Straße 17
    • 16321  Bernau
    • Germany
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Sources of Monetary or Material Support

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    • Medizinische Hochschule BrandenburgTheodor Fontane Campus BrandenburgProdekan für Forschung und Wissenschaft
    • Hochstraße 29
    • 14770  Brandenburg an der Havel
    • Germany
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    • Immanuel Klinikum Bernau Herzzentrum Brandenburg
    • Mr.  Univ.-Prof. Dr. med.  Christian  Butter 
    • Ladeburger Straße 17
    • 16321  Bernau
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.